Details for New Drug Application (NDA): 217656
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NDA 217656 describes ICOSAPENT ETHYL, which is a drug marketed by Apotex, Ascent Pharms Inc, Aurobindo Pharma Ltd, Dr Reddys, Hikma, Humanwell Puracap, Onesource Specialty, Qilu, Teva Pharms Usa, Torrent, Xiamen Lp Pharm Co, and Zydus Lifesciences, and is included in twelve NDAs. It is available from eighteen suppliers. Additional details are available on the ICOSAPENT ETHYL profile page.
The generic ingredient in ICOSAPENT ETHYL is icosapent ethyl. There is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the icosapent ethyl profile page.
The generic ingredient in ICOSAPENT ETHYL is icosapent ethyl. There is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the icosapent ethyl profile page.
Summary for 217656
| Tradename: | ICOSAPENT ETHYL |
| Applicant: | Zydus Lifesciences |
| Ingredient: | icosapent ethyl |
| Patents: | 0 |
Suppliers and Packaging for NDA: 217656
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ICOSAPENT ETHYL | icosapent ethyl | CAPSULE;ORAL | 217656 | ANDA | Softgel Healthcare Private Limited | 35916-1592 | 35916-1592-1 | 120 CAPSULE in 1 BOTTLE (35916-1592-1) |
| ICOSAPENT ETHYL | icosapent ethyl | CAPSULE;ORAL | 217656 | ANDA | Softgel Healthcare Private Limited | 35916-1738 | 35916-1738-1 | 240 CAPSULE in 1 BOTTLE (35916-1738-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 500MG | ||||
| Approval Date: | Apr 20, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 1GM | ||||
| Approval Date: | Apr 20, 2023 | TE: | AB | RLD: | No | ||||
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